COVID-19 update: FDA issues minor updates to guidance on hand sanitizer production

In March, the Food and Drug Administration (FDA) issued guidance documents, first revised on March 27, temporarily relaxing certain regulatory requirements for the production of alcohol-based hand sanitizers, to respond to the increased demand for hand sanitizer products during the novel coronavirus crisis.

Yesterday, FDA issued additional minor updates to these documents. Notably, FDA provides that fuel or technical grade ethanol should only be used if it meets food (or pharmaceutical) grade standards and has been screened for certain impurities. The agency invites companies wishing to use or supply fuel or technical grade ethanol that does not meet food-grade requirements to submit specified data to FDA for its review.

FDA also addresses several other topics, including the use of other technical grade ingredients, and the form of and packaging for the hand sanitizer. FDA maintains that ethanol used in hand sanitizers under the policy must be denatured using specified denaturants listed in the guidance, but continues to provide that companies may submit information on additional denaturants to the agency for consideration. FDA appears, however, to have ruled out acetone as a potential denaturant. This post summarizes the updates to the guidance documents as of April 15.

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